Kornimate/medical-research-clean huggingface dataset:
preoperative ultra-hypofractionated radiotherapy followed by surgery for retroperitoneal sarcoma

Conditions: Soft Tissue Sarcoma; Retroperitoneal Sarcoma; Radiotherapy Side Effect; Ultra-hypofractionated Radiotherapy; Stereotactic Ablative Radiotherapy

Summary: to investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma


Eligibility criteria:
inclusion criteria: * primary soft tissue sarcoma of retroperitoneal or infra-peritoneal spaces of pelvis * sarcoma not originated from bone structure, abdominal or gynecological viscera * all disease can be included safely within one radiotherapy field * absence of extension through the sciatic notch or across the diaphragm * histologically proven, excluding the following subtypes: gastro-intestinal stromal tumors (gist), rhabdomyosarcoma, pnet or other small round blue cells sarcoma, osteosarcoma or chondrosarcoma, aggressive fibromatosis, sarcomatoid or metastatic carcinoma * ecog performance status 0 to 2 * american society of anesthesiologist (asa) score ≤2 * normal renal function: calculated creatinine clearance ≥50ml/min（by cockcroft-gault formula）and functional contralateral kidney by differential renal isotope scan * normal bone marrow and hepatic function. * contraception was needed for female patients of child-bearing age, or male patients whose partner had child-bearing age * expected life expectancy longer than 5 years * written consent form was given prior to treatment * can safely be treated by radiotherapy and surgery exclusion criteria: * metastatic disease * tumor was previously treated by radiotherapy * involvement of liver, pancreatic head or duodenum

Keywords: stereotactic ablative radiotherapy hypofractionated radiotherapy retroperitoneal sarcoma soft tissue sarcoma peri-operative complications
long-term treatment study of mra for rheumatoid arthritis (ra) from study mra213jp

Conditions: Rheumatoid Arthritis

Summary: this is an open-label, extension, phase iii study to evaluate the long-term safety and efficacy of mra in patients with ra who participated in study mra213jp.


Eligibility criteria:
inclusion criteria * either mra or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety. * in the case of patients whose participation in the current study was judged to be inappropriate because of problems in the preceding study with respect to safety, these patients must have been in the methotrexate dose group in the preceding study. exclusion criteria * administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug * evaluated as belonging to steinbrocker's class iv within 4 weeks before administration of the study drug * have not been registered by 3 months after the full code-breaking of the preceding study * were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study * treated surgically (except for local surgery) within 4 weeks before administration of the study drug
safety and efficacy of using glucosat technology for non-invasive glucose measurement

Conditions: Diabetes

Summary: this study is a prospective, open label, controlled, single center study. 40 patients will be recruited for the study, according to patients' inflow and meeting eligibility criteria. primary goal \* to evaluate the safety of the glucosat technology as a non-invasive blood glucose level measurement technology. secondary goal \* to assess the efficacy of the glucosat technology as a non-invasive blood glucose level measurement technology.

primary endpoint parameter • primary study endpoint will be to establish the safety of using the glucosat technology as a non-invasive glucose level measurement technology. safety will be established by paucity of adverse events. adverse events occurrence will be documented throughout the study. secondary endpoint parameters efficacy of the glucosat technology will be assessed by: * proving the accuracy and precision of the glucosat technology by comparing the glucose level measured by the glucosat device to the glucose level observed by any certified for clinics invasive device. inter device variability should be within 15%. * patient satisfaction questionnaire. * physician satisfaction will be assessed by questionnaire.

Eligibility criteria:
inclusion criteria: * male/female aged 18 and up. * subject was diagnosed as a diabetes patient or healthy subject. * subject able to comprehend and give informed consent for participation in this study. * signed informed consent form exclusion criteria: * pregnancy or breast feeding. * patients treated with steroid. * concomitant coumadin use * recent (within the last 3 months) myocardial infarction or cva (stroke). * any chronic unstable disease within the last 3 months. * acute bleeding disorders. * hiv positive. * hepatitis b/c positive. * bmi\>37 * needing emergency surgery * known cognitive or psychiatric disorder * physician objection * concurrent participation in any other clinical trial
a comparison of hydrogel dressings and ocular lubricants in the prevention on corneal damage in the critically ill

Conditions: Keratitis

Summary: corneal damage in critically ill patients is common. there are currently two popular methods of treatment in the uk; hydrogel dressings and lubricating ointment. we propose to randomise patients to have a different treatment for each eye and see which one is more effective.

microbial keratitis, particularly pseudomonas-related, has been widely reported amongst intensive therapy unit (itu) patients and the need for effective eye care in itu has been recognised for some time. we compare two popular methods of eye care; a hydrogel dressing and lacrilube ointment. each recruited patient had each eye randomised to different treatments. daily ophthalmology ward rounds were undertaken to identify any corneal exposure keratopathy. patients were removed from the trial if one eye developed significant exposure needing treatment.

Eligibility criteria:
inclusion criteria: * all patients admitted to intensive care and expected to stay for more than 2 days exclusion criteria: * primary orbital injury

Keywords: keratopathy exposure intensive care eye ulcer corneal
prevalence of obesity among adult patients with congenital heart disease: a population-based study

Conditions: Obesity; Congenital Heart Disease

Summary: the study was conductede to examined the prevalence of obesity in a large danish achd cohort, stratified according to age, sex and disease severities. to do so, achd patients were matched by age and sex with controls from the contemporary copenhagen general population study


Eligibility criteria:
inclusion criteria: * congenital heart disease * bmi within the last five years exclusion criteria: * without bmi or not congenital heart disease

Keywords: obesity adult congenital heart disease
a study to evaluate iloperidone long-acting injection (lai) for the treatment of schizophrenia

Conditions: Schizophrenia

Summary: this is a multicenter, open-label, adaptive, repeat-dose study to evaluate the safety, tolerability, and pharmacokinetics of iloperidone long-acting injection (lai) in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent. * male or female patients 18 to 65 years of age (inclusive). * clinical diagnosis of schizophrenia according to the diagnostic and statistical manual of mental disorder (dsm-5) for at least 1 year. * symptomatically stable within the past two months. exclusion criteria: * use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. * any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs. * pregnant or nursing (lactating) women. * a positive test for drugs of abuse.
chlorhexidine to prevent catheter-related urinary tract infection

Conditions: Urinary Tract Infections

Summary: the study is to investigate whether chlorhexidine (chg)-based antiseptics is more effective to prevent catheter-related urinary tract infection (cauti) among inhospital patients who required foley catheter insertion. this is a cluster-randomised, step-wedged clinical trial, in which every participated unit will used three different foley catheter insertion protocols during the study period: 1. iodine protocol: using 10% povidone-iodine as the primary antiseptic during foley insertion. this is the routine practice before this study in the participated hospital, as well as many taiwanese hospitals. 2. chg protocol: instead of povidone-iodine solution, use 2% aqueous chg solution as the primary disinfectant during foley solution. 3. chg plus protocol: additional to 2% chg solution, added 0.5% chg impregnated gel as the lubrication during foley insertion.

this is a open-labelled, cluster-randomized, step-wedged clinical trial aimed to observe the incidence if cauti during the designated study period (12 months for all participated units). all included units will start with the iodine protocol, which is the standard practice in the hospital, and then switched to chg protocol than chg plus protocol according to the results of randomization. each unit will be randomized in to three different groups (a, b, and c): group a) 2 months of iodine protocol, followed by 4 months of chg protocol, followed by 6 months of chg plus protocol. group b) 4 months of iodine protocol, followed by 4 months of chg protocol, followed by 4 months of chg plus protocol. group c) 6 months of iodine protocol, followed by 4 months of chg protocol, followed by 2 months of chg plus protocol. all unit will be monitored and compared for the occurrence of cauti, which is defined in accordance to the definition from the national healthcare safety network (uscdc).

Eligibility criteria:
this is a cluster-randomized clinical trial. the enrollment is for healthcare units (wards, icus) in the participated hospitals rather than individuals. patients who were admitted in the included unit with be enrolled in our study automatically. inclusion criteria (for units): * adult acute care wards or intensive care units, which primarily care for adult patients aged above 18 years. * currently not using chlorhexidine as disinfectants for foley catheter insertion or routine care. * had patients who required foley catheter insertion during the last 12 months prior to inclusion. * willing to implant measures to improve the rate of cauti, and to participate and follow the study protocol in our study. exclusion criteria (for units): * units currently using chlorhexidine as disinfectants for foley catheter insertion or routine care. * wards or intensive care units with patients aged below 18 years of age in their routine practice.

Keywords: chlorhexidine catheter-related urinary tract infection disinfection bundle care foley catheter urinary catheter
functional characterisation of post-stroke fatigue

Conditions: Stroke; Stroke Sequelae

Summary: post-stroke fatigue is highly prevalent and disabling. however, its causes and consequences in the chronic phase are not fully understood. the aim of this cross-sectional study is to explore functional correlates of post-stroke fatigue in the chronic phase.


Eligibility criteria:
inclusion criteria: * mini mental state evaluation \> 24 * stroke \> 6 months ago exclusion criteria: * current active infection * multiple stroke * other affection of the central nervous system * medication potentially inducing severe fatigue * hospital admission during last month * severe apraxia * severe aphasia

Keywords: fatigue fatigability functional impairment
neural signatures of processing the temporal features of auditory events: from preterm infancy to adulthood

Conditions: Time Perception; EEG; Premature Neonates; Discrimination

Summary: premature neonates are able to discriminate phonemes and voice from 28wga at a time the neuronal network establish contact between the environment and the cortical neurones. in the present monocentric study the investigators will analyse the response of the cortical network in premature aged between 25 and 36 wga in response to auditory stimuli using high resolution electroencephalography and high density near infrared spectroscopy.

neurodevelopmental disorders may be related to functional or structural disruption of the neuronal network organization at an early stage or later in the course of development. the disruption of the initial set-up could partially explain the prevalence of neurodevelopmental risks due to prematurity. the development period between 25 and 33 wga corresponds to the period of very great prematurity and represents a key period of neurodevelopment in terms of structural and functional establishment of neuronal networks. one way to address the functionality of the neuronal networks is to evaluate the neural response to the exogenous stimuli and to interpret the mechanisms and the developmental status of the network in their ability to develop appropriate responses.

Eligibility criteria:
inclusion criteria: * full term neonates between 25 and 36 weeks gestational age exclusion criteria: * neonates outside the age range

Keywords: time perception rhythm eeg fnirs erp premature neonates discrimination
screening for synchronous metastases in colorectal cancer with dw-mri (serenade)

Conditions: Colorectal Neoplasms; Neoplasm Metastases; Hepatic Neoplasms

Summary: eligible patients with high risk colorectal malignancy (t3/4, spread greater than 5mm, emvi positive) will have additional surveillance of breath hold t1, t2 and dw-mris (no iv contrast) post surgery six monthly for three years. findings of liver mris as reported by radiology pi will be shared with their local mdt who make decisions as appropriate, including the management of any identified liver metastases, according to local protocol.

a phase ii multicentre, interventional study to determine if additional staging at diagnosis with liver dw-mri will diagnose more synchronous metastases than ct alone in patients with high risk colorectal cancer. liver metastases found on the additional dw-mri scans will be discussed at mdt and treated according to local policy.

Eligibility criteria:
inclusion criteria: 1. have a high risk primary colorectal malignancy 2. have a negative ct or includes no confirmatory evidence of liver metastases 3. is able to undergo treatment if liver metastasis is found 4. have provided written informed consent to participate in the study 5. be aged 16 years or over exclusion criteria: 1. have had a previous colorectal malignancy 2. have metastatic disease 3. have a synchronous second malignancy 4. are contraindicated for mri 5. has a t3b or below low rectal tumour without emvi or n1c

Keywords: colorectal neoplasms neoplasm metastases magnetic resonance imaging diffusion weighted mri hepatic neoplasms tumors neoplasms, rectal
efficacy study of intravenous iron preparation to iron deficiency anemia

Conditions: Iron Deficiency Anemia

Summary: the purpose of this study is to confirm the non-inferiority of z-213 compared to saccharated ferric oxide using the maximum change in hb from baseline over 12 weeks in patients with iron-deficiency anemia (ida)


Eligibility criteria:
inclusion criteria: * patients with iron deficiency anemia exclusion criteria: * patients with anemia caused by conditions other than iron deficiency * patients with abnormal laboratory test values at screening for serum phosphorus, aspartate aminotransferase, alanine aminotransferase * patients with liver, kidney or circulatory system disease * patients with a history or present illness that is a malignant tumor or autoimmune disease * patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening * patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening
raman probe for in-vivo diagnostics (during oesophageal) endoscopy

Conditions: Barrett Esophagus; Esophageal Cancer

Summary: to develop and endoscopic raman spectroscopy probe for delivery down and channel in an endoscope to make near instant assessments of the condition of the oesophagus without the need for expensive and distressing tissue removal (biopsies).

the investigators have already shown that it is possible to tell the difference between healthy and diseased tissue in the laboratory by looking at the light emitted by tissue when illuminated with a low power laser. the investigators intend to use this technique, known as "raman spectroscopy" to tell if tissue in the oesophagus is cancerous, healthy or at some stage before full blown cancer, which is termed pre-cancer. it has been shown in the laboratory that this method will be at least as accurate as the conventional methods used now, but will provide the surgeon with instant results without the delay and cost of a laboratory analysis by pathologists. a miniature probe has been developed that slides through a channel in the endoscope (telescope) to the surface of the oesophagus to make near instant assessments of its condition without the need for expensive and distressing tissue removal (biopsies). this project plans to move this technique from the laboratory to the clinic by demonstrating that the method is safe and reliable for use in real patients.

Eligibility criteria:
inclusion criteria: * barrett's oesophagus exclusion criteria: * unfit for endoscopic and biopsy assessment

Keywords: endoscopy raman spectroscopy
remediation of auditory recognition in schizophrenia with tdcs

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the purpose of this study is to determine whether transcranial direct current stimulation (tdcs), when combined with different forms of computer based training, improves the ability to discriminate small differences between sounds in people diagnosed with schizophrenia or schizoaffective disorder.

this study uses an experimental procedure called transcranial direct current stimulation (tdcs). little is known about how tdcs affects the brain or why some people diagnosed with schizophrenia or schizoaffective disorder have trouble with certain kinds of hearing. this study is being done to see if an experimental computer training program, when combined with tdcs, can help people to hear better. in tdcs, a small amount of electricity is passed through electrodes placed on the head that is able to stimulate the brain. by stimulating the brain, the investigators believe that the functioning of the brain can be altered. this study will test whether such stimulation of the brain, when done with computer training, can improve hearing ability and if this improvement helps in other ways, like detecting changes in someone's tone of voice or understanding other people's emotions better. the data being collected aims to better understand how the brain processes sounds and how tdcs affects the brain.

Eligibility criteria:
inclusion criteria: * age 18-55 * primary diagnosis of schizophrenia or schizoaffective disorder * english fluency * willing/capable to provide informed consent * auditory tone matching deficits * receiving stable doses of antipsychotic medication(s) for at least 2 weeks * iq\>75 exclusion criteria: * serious neurological disorder or medical condition/ treatment known to affect the brain. neurological disorder that affects the central nervous system (cns), such as epilepsy, neurodegenerative disorders, movement disorders and sensory disorders. * current or past history (within the last 6 months) of substance abuse or dependence (excluding nicotine) * pregnancy or breastfeeding * taking anticholinergic medication (e.g. cogentin, thorazine, clozaril, thioridazine)
evaluation of cissus verticillata l. infusion in controlling type 2 diabetes

Conditions: Diabetes

Summary: the purpose of this study was to investigate whether the infusion of a medicinal plant (cissus verticillata l.) would be effective in reducing glucose levels in blood and saliva of type 2 diabetes patients.

type 2 diabetes mellitus is regarded as one of the most prevalent disease of the adult population. in many developing countries, this condition is regarded as major public health problem. type 2 diabetes is a metabolic disorder characterized by high blood glucose related with a condition of insulin resistance and relative insulin deficiency. as diabetes progresses, medications are necessary to control glucose levels. the aim of this study was to investigate whether the infusion of a medicinal plant (cissus verticillata l.) would be as effective as a regular drug (glibenclamide) in reducing glucose levels in blood and saliva of type 2 diabetes patients. several medicinal plants have been used as potential medication for controlling glucose levels in diabetes patients. few studies have explored this effect related to cissus verticillata l.infusion, though it has been indicated by folk medicine of some latin american countries.

Eligibility criteria:
inclusion criteria: * subjects of 30 up to 80 years of age * positive diagnostic for type 2 diabetes mellitus (blood glucose level above 126 mg/dl) * patients that signed the informed consent exclusion criteria: * patients with renal and hepatic disfunction, * patients with cardiac problems or other systemic alterations (allergies, pulmonary and gastrointestinal problems) * pregnant women

Keywords: diabetes, medicinal plants, glucose
12-month open-label long-term safety study of tnx-102 sl tablets in fibromyalgia patients

Conditions: Primary Fibromyalgia

Summary: this was an open-label, extension trial designed to evaluate the long-term safety over 12 months of tnx-102 sl tablets taken daily at bedtime for the treatment of fibromyalgia. patients recruited into this trial were those who had successfully completed the double-blind study, tnx-cy-f202 (f202) (nct01903265). patients were not made aware of the therapy they received during the double-blind study.

the study consisted of 7 clinic visits, including screening/baseline visit 1 (day 0 which was typically the same date as visit 6 of the double-blind lead-in study), visits after 1, 3, 6, 9, and 12 months of treatment (visits 2-6), and a follow-up visit (visit 7) scheduled within one month after stopping study drug treatment. primary: the primary objective of the study was to evaluate the long-term safety of tnx-102 sl tablets taken daily at bedtime over 12 months in patients with fibromyalgia who have completed study tnx-cy-f202 (nct01903265) secondary: the secondary objective was to evaluate the long-term efficacy of tnx-102 sl tablets taken daily at bedtime to control symptoms of fibromyalgia

Eligibility criteria:
inclusion criteria: 1. the patient met all prior inclusion and exclusion requirements for study f202 (nct01903265) originally, and has had no intervening medical conditions, increased suicidal ideation, or requirements for concomitant medications that preclude exposure to tnx-102 sl or enrollment in the extension study. 2. the patient completed expected dosing in f202 (nct01903265) defined as taking study medication up to week 12, with at least 70% compliance with medication usage (based on responses from daily ivrs calls recorded during the f202 study (nct01903265)) and no major protocol violations. 3. the patient has provided written informed consent to participate in this extension protocol. exclusion criteria: none

Keywords: tnx-102 sl bedtime sublingual 12-month long term safety long term efficacy fibromyalgia